Adrenaline
Sold as Epipen, Epipen junior auto-injector, Ana-guard
4-[(1R)-1-Hydroxy-2-(methylamino)ethyl]benzene-1,2-diol
Drag to rotate. Structure from PubChem CID 5816.
Background
Registration
- Applicants
- 2
- Registrations
- 3
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Viatris Healthcare (Pty) LtdCertificate held by Mylan | Epipen, Epipen junior auto-injector | 0.15mg / 0.3ml, 0.3mg / 0.3ml | 270063, 380278 | S4 | PI |
| Bayer (Pty) Ltd û Isando | Ana-guard | Not stated | Y0030 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Epipen EACH 1 ml SOLUTION CONTAINS ADRENALINE 1 mg | 0.3mg / 0.3ml. 0.15mg / 0.3mlInjection | 27006327/5.1/0063Approved 7 July 2006 | Registered | S4 | PI |
| Epipen junior auto-injector EACH 0,3 ml SOLUTION CONTAINS ADRENALINE 0,15 mg | Not listed | 38027838/5.1/0278 | Registered | Not determined | None |
| Ana-guard EACH 1 ml INJECTION CONTAINS ADRENALINE 1,0 mg | Not listed | Y0030Y/5.1/30 | Registered | Not determined | None |
Regulatory status
Where S4 sits on the scale
Prescription-only medicine.
Schedule 4 covers most ordinary prescription medicines. You need a prescription from an authorised prescriber, such as a doctor or dentist, and a pharmacist dispenses it. Its price, name, pack size and strength can still be told to the public, as long as nothing links it to what it treats.
Schedule S4, read from the product's PI-PIL leaflet.
Who may supply: A pharmacist dispensing against a written or verbal prescription from an authorised prescriber; a veterinarian, who may also prescribe, compound or dispense it directly; a medical practitioner or dentist, who may prescribe it and may compound or dispense it directly only if licensed under section 22C(1)(a); manufacturers and wholesalers may supply people who may lawfully possess it; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
Consolidated Schedules listings for Adrenaline
S4: Adrenaline
- when intended for injection.
Consolidated Schedules 06 July 2026, line 5148
S3: Adrenaline
- ophthalmic preparations thereof, when intended for glaucoma.
Consolidated Schedules 06 July 2026, line 3122
S2: Adrenaline
- ophthalmic preparations when intended for glaucoma, and
- preparations for injection. (S3, S4)
Consolidated Schedules 06 July 2026, lines 1561 to 1565
Pharmacological class: Adrenomimetics (sympathomimetics). (class 5.1)
This is an informational summary of the Medicines and Related Substances Act 101 of 1965 and its 2017 General Regulations. It is not medical advice and not legal advice. Always check the medicine's label, which carries the schedule number inside a square border, or ask a pharmacist if you are unsure.
SAHPRA documents
Schedule Verification
Epipen, Viatris Healthcare (Pty) Ltd is scheduled S4 in its official SAHPRA documents, read with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.